Greenleaf Health, Inc. (Greenleaf) is seeking a Manager of Regulatory Affairs to perform research, analyze findings and draft documentation regarding the Food and Drug Administration’s (FDA’s) regulation of drug and biological products and medical devices. POSITION OVERVIEW This position will report directly to the Principals of the Drug and Biological Products Team and the primary function of this role will be to support Greenleaf’s drug and biological products clients. The optimal candidate should have, at a minimum, a firm grasp on the U.S. health care system and a basic understanding of the FDA’s role within the system. In addition, the optimal candidate has experience that highlights their ability to research, analyze, write and manage multiple projects simultaneously as well as their ability to work with clients. S/he will be an organized self-starter, able to work with moderate supervision, and flexible enough to thrive within a small and growing company. This is a full-time position based at Greenleaf’s Washington, DC headquarters.

RESPONSIBILITIES The job responsibilities include, but are not limited to, the following:

• Under general direction of Greenleaf’s Directors and senior level management, assist with research projects in the areas of drug, biological, and combination products;

• Facilitate information gathering and data collection for projects and reports; • Draft summaries of project findings and analyses;

• Track policy changes and announcements related to the FDA regulatory landscape;

• Assist with additional editorial duties including writing, reviewing and editing as needed;

• Participate in meetings with current and prospective clients; and • Perform other duties as assigned.

QUALIFICATIONS Interested candidates should meet the following qualifications:

• Bachelor’s degree required; Master’s degree a plus

• Excellent research, analytical and writing skills

• Solid experience using Microsoft Office and G Suite (Google); Mac experience a plus

• Exceptional verbal and written communication skills 2

• Strong interpersonal skills

• Keen attention to details

COMPENSATION/BENEFITS Greenleaf provides a challenging and engaging work environment, while offering flexibility to maintain an optimal work-life balance. Benefits are provided to employees working 30+ hours per week. These include: health, dental, vision and life insurance; 401(k) plan with employer match; generous paid leave/time off policy; and indoor parking. Compensation is commensurate with professional experience.

ABOUT GREENLEAF HEALTH Greenleaf is a leading FDA regulatory consulting firm that provides strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies researching, developing, and manufacturing innovative solutions to pressing global public health challenges. Greenleaf is committed to serving clients’ needs with extensive expertise, unwavering integrity, and strategic insight in a manner that supports availability of safe, effective, and high-quality drugs, biologics, and medical devices. With decades of experience in senior positions at the FDA and industry, Greenleaf’s team of respected professionals brings unmatched expertise that companies need when working directly with the FDA and when navigating today’s evolving regulatory environment. For more information about Greenleaf, please visit our website at greenleafhealth.com.

HOW TO APPLY Interested applicants should submit employment-related documentation (resume, CV) to careers@greenleafhealth.com

Health Policy Client Service Assistant Job Description

McDermott+Consulting is a Washington DC-based healthcare consulting firm, serving a wide range of clients including physician medical specialty societies, other provider organizations and industry healthcare organizations. The Health Policy Client Service Assistant (CSA) will work with all members of the McDermottPlus team to support the development of policy insights, identification of policy alternatives, analyze and frame issues and challenges and advance business solutions for clients. The CSA will have the opportunity to delve into a variety of projects and gain valuable knowledge and understanding of key issues within the nation’s health care system.

Key duties of the CSA include, but are not limited to:

• Support tracking and analyzing key federal and state health care legislative initiatives and policy developments
• Cover, attend, and report on Congressional hearings, MedPAC, MACPAC, and policy stakeholder meetings
• Develop fact sheets, testimony, infographics, and other materials for clients and public distribution
• Conduct Medicaid waiver research
• Provide timely updates and turnarounds of breaking legislation and pressing issues
• Conduct legislative research and bill analysis
• Assist in the collection of relevant health care data
• Learn about the health care policy process in Washington and how policy reforms impacts the health care market

Position Requirements:

Candidates must be at least a college senior – graduate MPH or MPP students strongly preferred. All candidates must have an interest in health policy. Candidates should be able to dedicate at least 24 hours per week for the duration of the internship.

Strong written and oral communications skills are imperative. Candidates should have initiative, be highly organized, able to manage multiple projects and deadlines, and attentive to detail.

The following information must be submitted upon application:

• Resume
• Writing sample
• Cover letter

Send information to emmazimmerman@mcdermottplus.com.